FDA 510(k) clearances — page 114
clearances on record, most recent first.
Clearances — page 114
11,301–11,400 of 175,620- K223406 — SmartRelease Endoscopic Soft Tissue Release System
- K223627 — PreView-III Anterior Cervical Plate System
- K230012 — Atomica Planner
- DEN220014 — RefleXion Medical Radiotherapy System (RMRS)
- K213480 — 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
- K221168 — Tinnitogram Signal Generator
- K221943 — EmbedMed
- K222751 — LED Light Therapy Device, KN-7000L
- K222863 — Garment Electrodes
- K222970 — LVivo IQS
- K223330 — Certas Plus Programmable Valves
- K223396 — Rapid RV/LV
- K230020 — BriefCase
- K221200 — XBody Go USA, XBody Pro USA
- K223117 — V-SPERM WASH
- K223351 — Naviswiss Knee
- K210112 — XChange Device, XChange System
- K221532 — PHMB Wound Dressing
- K222567 — Playground For All Love Sesh
- K223348 — My3D® Personalized Pelvic Reconstruction
- K212684 — BrainView QEEG Software
- K203833 — Tacrolimus Assay Kit
- K210166 — Omnispec ED1000
- K211559 — EasyStat 300
- K213059 — Tibia and Fibula System
- K220803 — VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
- K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- K221338 — F&P Airvo 3
- K221551 — FUJIFILM Endoscope Model EI-740D/S
- K221868 — QOCA image Smart CXR Image Processing System
- K222664 — Sim&Size
- K222835 — Prophecy Preoperative Navigation Alignment System
- K222901 — EVA15 insufflator
- K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
- K223090 — GEM Premier ChemSTAT
- K223254 — C2 Xplore
- K223546 — 14HQ721G-B
- K223903 — Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)
- K223927 — 360CAS
- K220073 — RMF-2000
- K221424 — Sterile Surgical Powder Free Latex Glove
- K221619 — ECHELON Oval V6.2 MRI System
- K221949 — Ortho Device, ADAPTIX 3D Orthopedic Imaging System
- K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
- K222403 — Surgical Gown
- K222437 — Aristotle Colossus Guidewire
- K222589 — Flexible Suturing System with Anchors (FSSA)
- K222779 — Revogene
- K223415 — Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K223588 — PALLAS Premium
- K220114 — PowerPAK Syringe
- K221150 — Advanced Bone Plate
- K222665 — Medline UNITE® Ankle Fusion Plating System
- K222801 — Safety Lancet
- K223306 — SPRINT Peripheral Nerve Stimulation (PNS) System
- K223314 — Disposable Blood Lancets
- K223563 — OsteoCNX
- K223847 — CREED Cannulated Screws
- K223866 — Carevix Suction Cervical Stabilizer
- K222818 — Xpedition Powered Stair Chair (625700000000)
- K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
- K203689 — Tidepool Loop
- K221494 — Quality Mix Blender, Oxymixer
- K222406 — Clarius AI
- K223158 — LigaSure XP Maryland Jaw Sealer/Divider
- K223313 — Disposable Safety Lancets
- K223494 — CD Horizon Spinal System
- K222531 — Synthetic Polymer Glove - Polyethylene (Black)
- K222832 — Sentimag System
- K223118 — OIC Variable Angle Small Fragment Locking Plate System
- K223516 — VX1+
- K203792 — Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
- K214077 — Digital Thermometer, Model: DT007, DT008
- K221419 — TD-5010 Lancing Device and TD-5084 Sterile Lancets
- K221683 — CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
- K221725 — Advanced MyHip Planner
- K221899 — The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
- K222158 — Capiflo 5001
- K222462 — Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)
- K222510 — Blueprint Mixed Reality system
- K222848 — pRESET Thrombectomy Device
- K222889 — FlowArt® Needle-Free Split Septum Valve
- K223177 — Highlander 014 PTA Balloon Dilatation Catheter
- K223404 — Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
- K223521 — ZESPIN SI Joint Fusion System
- K223528 — Triathlon® Hinge Knee System
- K223548 — GMK Sphere & GMK SpheriKA Cementless
- K223842 — DRX - Compass
- K211197 — Disposable Endoscopic Cutter Stapler and Cartridge
- K213175 — No Stress Impress
- K213772 — LM-9300 Plus Lithotripter
- K220059 — Biosci Inactivated Transport Medium, Biosci ITM
- K220448 — Disposable Non-invasive EEG Sensor
- K221163 — Tunnel Crossing Catheter
- K221522 — HF-cables (resusable)
- K221627 — PerfusionGo Plus
- K222252 — Self-adhesive Electrode
- K222554 — EL CAPITAN Anterior Lumbar Interbody Fusion
- K223108 — TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
- K223166 — Medaica M1 Telehealth Stethoscope
Data sourced from openFDA. This site is unofficial and independent of the FDA.